workshop: Global health drug development
TUESDAY, APRIL 4, 2017
The need for innovation in development of and access to healthcare products for global health applications has never been greater, while at the same time the issues facing the developers and manufacturers have never been more complicated.
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Developing and distributing medicines and vaccines for a global market involves expanded challenges and issues for the parties involved. Done well, these developments are smooth alliances between multi-functional organizations funded by both public and private organizations. Optimally, the resulting products benefit not just traditional markets but also those in less developed countries and regions. In order to achieve these goals, certain elements are essential:
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Innovation
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Development capabilities
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Funding sources
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Global clinical trials
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The strategic and social use of intellectual property
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Alliance capabilities
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Distribution networks
Join the Global Health Innovation Alliance Accelerator and the Triangle Global Health Consortium on April 4th for a workshop exploring the concerns facing start up companies, spin-offs from universities, institutes, the US government and traditional pharmaceutical companies as they partner to develop and distribute new medicines and vaccines.
Attendees will gain practical skills and knowledge on a broad range of issues, including meeting requirements for partnering with the NIH, foundations, and clinical trial organizations; negotiating license agreements; and managing clinical trials in low and middle income countries. Networking opportunities will be incorporated throughout the day.
Hosted by
Global Health Innovation Alliance Accelerator
Triangle Global Health Consortium
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​Where
NC Biotech Center
15 TW Alexander Dr, Durham, NC 27703
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When
Tuesday, April 4, 9:00am-4:00pm
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Cost
Professionals - $65
Students - $40
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Agenda
8:30-9:00 AM
Registration
9:00-9:15 AM
Introductions and Welcome
Julie Barnes-Weise, Claire Neal
9:15-9:35 AM
Critical needs in global health development
Chris Woods
9:35-10:05 AM
Vaccine development challenges for emerging diseases
Kevin Gilligan
10:05-10:35 AM
The role of patents in building a building a global health product business
Arles Taylor
10:35-11:00 AM
The impact of the FDA on global health product development through incentives such as the Priority Review Voucher system
Jeffrey Moe
11:00-11:15 AM
Break
11:15-11:45 AM
Life cycle management versus evergreening – how the rest of the world looks at the US and EU pharma market patents. How will access be addressed?
Rosa Castro
11:45-12:15 PM
Building a sustainable global health business – non-profit or for profit
Rita Khanna
12:15-12:45 PM
Panel: Developing country markets - the economics of partnering a global health product
Rita Khanna and Vishy Pingali
12:45-1:30 PM
Lunch: Federal funding and global health, a look ahead
Greg McDonald
1:30-1:45 PM
Universities as alliance innovators
Mark Crowell
1:45-2:00 PM
The role of a university technology office in finding partners for global health technologies
Robin Rasor
2:00-2:15 PM
The GHIAA Tech Transfer Access to Medicines survey project
Robin Rasor and Kushal Kadakia
2:15-2:45 PM
Ownership of data in a global licensing and development agreement
Julie Watson
2:45-3:05 PM
Alliances for increasing access to medicines for outbreaks and less developed countries
Julie Barnes-Weise
3:05-3:20 PM
Break
3:20-3:40 PM
Bringing global technologies home – licensing with an international institute
Kevin Boggs
3:40-4:10 PM
Panel: Global health licensing
Julie Barnes-Weise, Kevin Boggs, Mark Crowell, Julie Watson
4:10-4:30 PM
Q&A and conclusions
SPEAKERS
Executive Director of Global Health Innovation Alliance Accelerator
Senior Manager of Global Licensing, Research Triangle Institute
Postdoctoral Associate, Duke Science and Society
Principal, Academy Innovation Advisors
Senior Scientific Advisor at Clinical Research Management, Inc. (ClinicalRM)
Student Member, Global Health Innovation Alliance Accelerator
Vice President of Government Relations, RTI International
Professor of the Practice of Global Health, Duke Global Health Institute
2016-17 George C. Lamb, Jr. Regulatory Fellow at the Kenan Institute for Ethics, Duke University
‎Executive Director, Office of Licensing and Ventures, Duke University
‎Principal at Jenkins, Wilson, Taylor, & Hunt, P.A.
Special Counsel, Marshall, Gerstein
Professor of Medicine and Global Health and Director of Graduate Studies, Duke Global Health Institute